MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.TF1.LM TIBIAL TRAY FIX CEMENTED S1 LM; KNEE TIBIAL TRAY FIX CEMENTED

Catalog Number 02.18.TF1.LM

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 29 february 2024 lot 2302384: (b)(4) items manufactured and released on 15-jun-2023.Expiration date: 2028-05-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: subsidence of the tibial component in a cemented medial uka.Date of primary surgery unspecified.Presumably the adverse event took place shortly after index operation.Apparently, the bone coverage was insufficient to offer adequate primary stability.This may be due to difficulties in size selection or placement of the component, but of course other patient-specific factors, as well as postoperative protocol, may have influenced, although the bone quality appears radiographically to be rather good.The definitive cause for subsidence cannot be identified with the information at hand.

Event Description

Revision surgery for tibial tray subsidence.All implants were removed and gmk revision with semiconstrainted liner was implanted successfully.

• Brand Name: MOTO PARTIAL KNEE 02.18.TF1.LM TIBIAL TRAY FIX CEMENTED S1 LM
• Type of Device: KNEE TIBIAL TRAY FIX CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18950504
• MDR Text Key: 338253125
• Report Number: 3005180920-2024-00136
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896699
• UDI-Public: 07630030896699
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.18.TF1.LM
• Device Lot Number: 2302384
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White